Clinical Research Associate II Jobs at Parexel Bengaluru for experienced clinical research professionals. Check responsibilities, skills, eligibility, and apply online.
Parexel Hiring Clinical Research Associate II in Bengaluru – Full Job Details
Parexel, a globally recognized leader in clinical research and biopharmaceutical services, is inviting applications for the position of Clinical Research Associate II (CRA II) in Bengaluru, India. This role is ideal for experienced clinical research professionals who have strong site management experience and a solid understanding of ICH-GCP guidelines, clinical trial operations, and regulatory requirements. Clinical Research Associate II Jobs at Parexel
Parexel is known for its commitment to improving global health through ethical, high-quality clinical research. As a CRA II, you will play a vital role in ensuring that clinical trials run smoothly, patients remain safe, and study data meets the highest standards of accuracy and integrity. Clinical Research Associate II Jobs at Parexel
This long-format job post provides complete information about the role, responsibilities, required skills, qualifications, and the application process. Clinical Research Associate II Jobs at Parexel
About the Clinical Research Associate II Role
The Clinical Research Associate II (CRA II) serves as the primary point of contact between Parexel and clinical trial sites. You will be responsible for ensuring site readiness, monitoring ongoing study activities, addressing site-related issues, and maintaining compliance throughout the study lifecycle—from site identification to trial close-out. Clinical Research Associate II Jobs at Parexel
The main objective of this role is to ensure that each site performs optimally, follows the study protocol strictly, and adheres to all applicable regulatory and ethical standards. You will lead site-level performance, support patient recruitment strategies, ensure complete documentation, and maintain high study quality. Clinical Research Associate II Jobs at Parexel
This role requires excellent communication, relationship-building abilities, problem-solving skills, and strong attention to detail. Candidates must also be comfortable working independently and managing multiple priorities in a fast-paced clinical research environment. Clinical Research Associate II Jobs at Parexel
Key Responsibilities
1. Site-Level Oversight and Monitoring
- Serve as Parexel’s direct point of contact for all assigned clinical sites.
- Conduct qualification, initiation, monitoring, and close-out visits.
- Ensure the protection of patient rights, safety, and well-being throughout the study.
- Evaluate the integrity and accuracy of reported study data.
- Assess site readiness for study activities and support completion of essential documents.
2. Ensuring Regulatory Compliance
- Verify that clinical sites comply with ICH-GCP, study protocols, and applicable local regulations.
- Collect, review, and approve regulatory documents, amendments, and essential site files.
- Ensure sites are always inspection-ready for audits and regulatory checks.
3. Supporting Site Training and Engagement
- Provide protocol-specific and system-specific training to site staff as needed.
- Build strong working relationships with investigators and site personnel.
- Assess the need for retraining and ensure training is completed on time.
4. Issue Resolution and Site Support
- Identify data discrepancies, protocol deviations, or compliance issues during monitoring.
- Work with cross-functional teams to develop and implement corrective action plans.
- Address site queries promptly and offer solutions to operational challenges.
5. Patient Recruitment Strategy
- Evaluate ongoing patient recruitment progress at each site.
- Work with site teams to develop strategies to boost patient enrollment.
- Monitor screening logs, dropout rates, and enrollment timelines.
6. Data Oversight and System Updates
- Ensure timely and accurate updates in Clinical Trial Management Systems (CTMS).
- Monitor CRF data entry, query resolution, and adverse event reporting.
- Submit documents to the Trial Master File (TMF) with first-time accuracy.
7. Study Supplies and Test Article Management
- Track investigational product (IP) supply, accountability, returns, and destruction.
- Verify storage conditions, IP handling, and site inventory status.
8. Collaboration with Internal Teams
- Work closely with Clinical Operations Leaders, project managers, and other stakeholders.
- Participate in investigator meetings, audits, inspections, and internal reviews.
- Delegate tasks to administrative support teams when appropriate.
General Accountabilities from Site Selection to Close-Out
- Ensure timely completion of all study milestones.
- Maintain accurate documentation across CTMS, EDC, and IVRS systems.
- Support ongoing planning and execution of project-level activities.
- Provide feedback and recommendations for process improvement.
- Maintain a strong understanding of study timelines and project budgets.
- Demonstrate consistent, high-quality performance across all assigned tasks.
Clinical Research Associate II Jobs at Parexel
Required Skills and Competencies
The ideal candidate for the CRA II role should possess the following skills: Clinical Research Associate II Jobs at Parexel
Technical and Professional Skills
- Solid understanding of clinical trial methodology and terminology.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Experience using CTMS, EDMS, EDC systems, and MS Office.
- Ability to identify data integrity issues and resolve them independently.
Interpersonal and Behavioral Skills
- Excellent communication and presentation skills.
- Ability to work efficiently in a matrix and multicultural environment.
- Flexibility in handling shifting priorities and new challenges.
- Strong time management and organizational skills.
- Capability to build strong professional relationships with clinical site staff.
Additional Attributes
- High attention to detail.
- Ability to work with minimal supervision.
- Willingness to travel extensively based on study requirements.
- Sense of urgency in delivering assigned tasks and maintaining patient safety.
Experience Requirements
- Mandatory site management experience or equivalent clinical research experience.
- Experience in monitoring clinical trials and interacting with investigator sites.
- Understanding of clinical operations, study documentation, and trial life cycle.
Educational Qualification
- Bachelor’s degree in Biological Sciences, Pharmacy, Nursing, or related health disciplines.
- Equivalent professional experience in clinical research may also be considered.
Why Work with Parexel?
Parexel is recognized for its ethical work culture, global exposure, and commitment to innovation in clinical research.
By joining as a CRA II, you gain: Clinical Research Associate II Jobs at Parexel
- Opportunities to work on international clinical trials.
- Continuous professional development and training.
- A collaborative, supportive, and growth-oriented work environment.
- The chance to contribute to life-changing medical advancements.
How to Apply
Eligible and interested candidates can apply for the Clinical Research Associate II position through Parexel’s official careers portal. Clinical Research Associate II Jobs at Parexel
Once on the application page:
- Click on Apply Now.
- Create or log in to your Parexel career account.
- Upload your updated resume and fill in the required details.
- Submit your application.
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